NCT02410486|CompletedDMC
Early-Onset Sepsis an NICHD/CDC Surveillance Study
EOSII
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EOSII
Sponsor study identifier
Secondary identifiers
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observational
570
1 country
20
Study Start
April 2015
Actual (reported)Primary Completion
December 2017
Actual (reported)Study Completion
December 2017
Actual (reported)This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2015
Actual (reported)April 2, 2015
Actual (reported)April 7, 2015
Actual (reported)December 2017
Actual (reported)December 2017
Actual (reported)To determine current hospital-based rates of early-onset neonatal infection
First 72 hours
To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM
First 72 hours
To identify risk factors associated with EOS/EOM due to Gram-negative pathogens (case control comparison)
First 72 hours
To determine the clinical signs/symptoms and laboratory abnormalities associated with EOS/EOM
First 72 hours
To identify risk factors for EOS/EOM in infants born to mothers with chorioamnionitis (case control comparison)
First 72 hours
To determine if term infants with EOS, identified because of maternal chorioamnionitis, can be asymptomatic at birth
First 72 hours
To determine sepsis-associated mortality rates (total, GA-specific and BW-specific, pathogen-specific) for infants with EOS/EOM
First 72 hours
Infant with EOS (Gram-positive or Gram-negative) and mother with Chorioamnionitis
Infant with EOS (Gram-positive or Gram-negative) and mother without Chorioamnionitis
Infant with Gram-negative EOS and mother with Chorioamnionitis
Infant with Gram-negative EOS and mother without Chorioamnionitis
Infant with Gram-positive EOS and mother with Chorioamnionitis
The study population will include all live born infants who are at least 22 weeks GA and have a birth weight \>400 grams and are delivered at NRN centers.
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California - Los Angeles
Los Angeles, California, 90025, United States
Stanford University
Palo Alto, California, 94304, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Wayne State University
Detroit, Michigan, 48201, United States
Kilpatrick R, Greenberg R, Hansen NI, Shankaran S, Carlo WA, Cotten CM, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Use and utility of C-reactive protein (CRP) in neonatal early-onset sepsis: a secondary analysis of a prospective surveillance study. J Perinatol. 2025 Jan;45(1):139-145. doi: 10.1038/s41372-024-02064-5. Epub 2024 Aug 5.
Barbara Stoll, MD
The University of Texas Health Science Center, Houston
Michele Walsh, MD
Case Western Reserve University, Rainbow Babies and Children's Hospita
Seetha Shankaran, MD
Wayne State University
Abbot Laptook, MD
Brown University, Women & Infants Hospital of Rhode Island
570 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2015
First Posted
April 7, 2015
Study Start
April 2015
Actual (reported)Antibiotic Therapy for Early Onset Neonatal Sepsis
Contact the study team to confirm eligibility.
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
University of Rochester
Rochester, New York, 14642, United States
RTI International
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02912, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Michael Cotten, MD
Duke University
Greg Sokol, MD
Indiana University
Abhik Das, PhD
RTI International
Krisa Van Meurs, MD
Stanford University
Brenda Poindexter, MD
Children's Hospital Medical Center, Cincinnati
Waldemar Carlo, MD
University of Alabama at Birmingham
Kristi Watterberg, MD
University of New Mexico
Myra Wyckoff, MD
University of Texas, Southwestern Medical Center at Dallas
Kathleen Kennedy, MD, MPH
The University of Texas Health Science Center, Houston
Barbara Schmidt, MD
University of Pennsylvania
Carl D'Angio, MD
University of Rochester
Pablo Sanchez, MD
Research Institute at Nationwide Children's Hospital
William Truog, MD
Children's Mercy Hospital Kansas City
Uday Devaskar, MD
University of California, Los Angeles
Bradley Yoder, MD
University of Utah
Primary Completion
December 2017
Actual (reported)Study Completion
December 2017
Actual (reported)Last Updated
March 11, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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